Method of cancer screening; method of cancer treatment; and method of diabetes treatment

ABSTRACT

A method of cancer screening comprising the steps of administering the Blood CA 27,29 testing procedure; if the result is positive administering a mammogram; if the result is positive administering an needle biopsy; if the result is positive administering a PET scan; if the result is positive administering a blood tumor cell count. If all of the foregoing steps are positive, the cancer is treated by applying imiquimod transdermally to rotating sites, preferably by mixing ALDARA™ (imiguimod) 5% cream with an equal amount of H base cream™; administering a vaccine containing tumor necrosis factor alpha, preferably the BCG vaccine; and orally administering VALTREX™ (valacyelovir) twice daily. The foregoing treatment method is also effective in treating Type I diabetes, MS, and other epidermal cancers.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of application Ser. No.______ filed Dec. 3, 2004 (our file 120175-1005), currently pending,which is a which is continuation-in-part application of application Ser.No. 10/946,213 filed Sep. 21, 2004, currently pending.

TECHNICAL FIELD

This invention relates generally to the detection and treatment ofcancers, and more particularly to a method of screening for and a methodof treating duct cell cancer of the breast, squamous cell cancer of theuterine cervix, anal cancer, diabetes, and multiple sclerosis.

BACKGROUND AND SUMMARY OF THE INVENTION

As is well known, various technologies are available to the medicalprofession for use in determining the presence of cancers in patients.Included are x-ray studies, magnetic resonance imaging (MRI) studies, CTscans, as well as studies of various body fluids such as blood, urine,etc. Potential sites for colon cancer, for example, can be investigatedutilizing electro-optical technologies. In some cases needle biopsy orexploratory surgery is necessary to confirm either the presence orabsence of suspected cancer.

Various techniques for treating cancers are also well known. Certaincancers can be surgically removed, whereas other cancers requireradiation therapy, chemotherapy, or combinations of radiation therapyand chemotherapy. Other cancers are susceptible to control using one ormore drug therapies.

Type I diabetes is generally diagnosed in juveniles and young adults. Intype I diabetes, the pancreas does not make insulin, which is necessaryfor the body to process sugars. Persons with Type I diabetes can livelong, healthy lives, but must be careful with their diet and must takeinsulin to manage their blood glucose levels. Currently, the onlytreatment for Type I diabetes is to take insulin, or receive pancreas orislet cell transplants.

Multiple sclerosis (MS) is a chronic, unpredictable disease of thenervous system that afflicts over 2.5 million persons worldwide. An MSattack destroys myelin, the protective fibers around nerve fibers in thecentral nervous system. The destroyed myelin is replaced by scars ofhardened “sclerotic” tissue, and some nerve endings are permanentlysevered. The common symptoms are loss of balance, fatigue, poorcirculation, slurred speech, blindness, and in some cases paralysis.Currently, the only treatment is disease-modifying drugs, includingdrugs with a chemotherapeutic agent. These treatments only modify thedisease to lessen the severity or frequency of the MS attacks.

The present invention comprises a method of cancer screening, a methodof cancer treatment, a method for treatment of diabetes, and a methodfor treatment of multiple sclerosis which has proven successful incontrolling epidermal cancers including, but not limited to, duct cellbreast cancer, cervical squamous cancer, and anal cancer, controllingType I diabetes, and controlling multiple sclerosis. In accordance withthe broader aspects of the invention, a method of cancer screeninginvolves a series of testing procedures each more expensive than the onebefore. Only when results of each of the testing procedures are positiveis the presence of cancer confirmed. The invention further comprises amethod of treating cancer and insulin dependent Type I diabetes whereinthe drug imiquimod is administered transdermally in conjunction with avaccine containing tumor necrosis factor, for example the BCG vaccine,and valacyclovia hydrochlorine tablets. The method of the presentinvention treats Type I diabetes by enabling the body to regenerateislet cells. Similarly, multiple sclerosis is managed and treated byenabling the body to repair nerve endings and regenerate damaged fibers.

BRIEF DESCRIPTION OF THE DRAWING

A more complete understanding of the present invention may be had byreference to the following Detailed Description when taken in connectionwith the accompanying Drawings, wherein:

FIG. 1 is a flowchart illustrating initial steps in the cancer screeningmethod of the present invention;

FIG. 2 is a flowchart illustrating subsequent steps in the cancerscreening method of the present invention; and

FIG. 3 is a flowchart illustrating the diabetes treatment method of thepresent invention.

DETAILED DESCRIPTION INTRODUCTION

The following examples describe a method of detecting and treating ductcell breast cancer, and a method for treating Type I diabetes. However,the present invention is equally applicable to other epidermal cancers,such as squamous cancer of the uterine cervix and anal cancer, and thetreatment of and management of multiple sclerosis.

EXAMPLE

Referring to the Drawings, and particularly to FIG. 1 thereof, the earlysteps in the method of cancer screening of the present invention areshown therein. Screening begins with administration of the testingprocedure known as Blood CA 27,29. The Blood CA 27,29 testing procedurehas heretofore been utilized in monitoring the results of existingcancer treatment procedures. However, the Blood CA 27,29 procedure hasnot heretofore been used for cancer screening.

If the number comprising the results of the Blood CA 27,29 procedure isless than 20, and if there has been no increase in the number comprisingthe result of the Blood CA 27,29 testing procedure of ten (10) or morein the immediately preceding year, the result of the Blood CA 27,29testing procedure is considered to be negative. The patient is thenscheduled for follow-up testing utilizing the Blood CA 27,29 procedurein one year.

If the number comprising the result of the Blood CA 27,29 procedure is20 or above, or if there has been an increase of 10 or more in thenumber comprising the result of the CA 27,29 testing procedure in theimmediately preceding year, the result of the Blood CA 27,29 procedureis considered to be positive. In that event a mammogram testingprocedure is administered. If the result of the mammogram testingprocedure is negative, an MRI testing procedure is administered. If theresult of the MRI testing procedure is negative, both the mammogramtesting procedure and the Blood CA 27,29 testing procedure arere-administered in six months time. Conversely, if either the mammogramtesting procedure is positive or the MRI testing procedure is positive,a needle biopsy of the identified lesion is performed.

Referring to FIG. 2, if the results of the needle biopsy testingprocedure are negative, both the mammogram testing procedure and theBlood CA 27,29 testing procedure are re-administered in six months. Ifthe needle biopsy testing procedure is positive, a positron emissiontomography (PET) scan testing procedure is administered. If the resultof the PET scan testing procedure is negative, the mammogram testingprocedure and the Blood CA 27,29 testing procedure are re-administeredin six months. If the result of the PET scan testing procedure ispositive, a blood tumor cell count testing procedure is administered. Ifthe result of the blood tumor cell count testing procedure is negative,that is, if the number comprising the result of the blood tumor cellcount testing procedure is between 0 and 1.5, the blood tumor cell counttesting procedure and the Blood CA 27,29 testing procedure areadministered at three month intervals. Conversely, if the blood tumorcell count testing procedure is positive, that is, if the numbercomprising the result of the blood tumor cell count testing procedure istwo or above, the cancer treatment procedure of the present invention isadministered.

The cancer treatment procedure of the present invention comprises thetransdermal administration of the drug imiquimod combined with a vaccinecontaining tumor necrosis factor and administration of valacycloviahydrochlorine tablets. Imiquimod is commercially available from 3MPharmaceuticals under the trademark ALDARA™. A healthy human bodyproduces the protein interferon alpha in response to an infection.Interferon alpha works to coat the infection or virus in order to makethe infection or virus vulnerable to the human immune system. Imiquimod,i.e. ALDARA™ cream, turns into interferon alpha once inside the humanbody, providing the needed interferon alpha not adequately produced bythe patient's own body. In accordance with the present invention,ALDARA™ cream 5% is mixed at a 1:1 ratio with H base cream. Theingredients of H base cream are:

-   -   water, glycerin, canola oil, stearic acid, cetyl alcohol,        PEG-100 stearate, glyceryl stearate, dimethicone, magnesium        aluminum silicate, propylene glycol, triethanolamine,        polysorbate 60, xanthan gum, bitter almond kernel oil, aloe        vera, grape seed extract, wheat germ oil, vitamin E acetate,        vitamin A palmitate, Vitamin C palmitate, tetrasodium EDTA,        potassium sorbate, diazolidinyl urea. H base cream is a        proprietary product produced by Professional Compounds Centers        of America and licensed by it.        The mixture of imiquimod and H base cream as described above is        administered transdermally, preferably by mixing ¼ cc ALDARA™ 5%        cream with ¼ cc H base cream and applying the resulting mixture        to various locations, i.e., the inner thigh, abdomen, hip, arms,        etc., of the patient. Various sites of administration prevent        any possible skin irritation. The foregoing amount of the        mixture of ALDARA™ 5% cream and H base cream is applied daily.

Tumor necrosis factor (also called TNFa, cachexin, or cachetin)stimulates T-cells that coordinate the immune system. In a healthy humanbody, tumor necrosis factor is released by white blood cells and othertissues in response to damage caused by an infection. Tumor necrosisfactor is found in several vaccines. The preferable vaccine to be usedin accordance with the present invention is the BCG vaccine, which is acommon vaccine for tuberculosis, given in the United States and aroundthe world. The tumor necrosis factor included in the BCG vaccine andimiquimod, i.e. ALDARA™ cream, work together to stimulate the T-cellsand coordinate and improve the patient's immune system. Interferon alphacoats the virus or infection in order to make the virus or infectionvulnerable to the tumor necrosis factor.

In accordance with the present invention, the vaccine is given in dosesof 0.1 mL (100 μg) once every three weeks as long as the treatmentcontinues. Valacyclovia hydrochlorine tablets, available fromGlaxoSmithKline under the trademark Valtrex™ is drug commonly used inthe treatment for genital herpes. In accordance with the presentinvention, Valtrex™ tablets are consumed twice daily in 500 mg doses.The combination of the ALDARA™ and H base cream, the BCG vaccination,and the Valtrex™ tablets is administered until a blood tumor cell countindicates that there are no cancer cells in the blood and a subsequentblood tumor cell count verifies a normal cell count and no mestastasesare present. The results of the procedure are periodically monitoredutilizing the Blood CA 27,29 testing procedure.

Referring to FIG. 3 thereof, persons with Type I diabetes must checktheir blood glucose levels at multiple intervals as directed by theirphysician. The average fasting blood glucose level should be between 70mg/dL and 110 mg/dL. If the blood glucose level is not within the targetlevel, the level must be corrected by taking insulin.

The diabetes treatment procedure of the present invention comprises thetransdermal administration of the drug imiquimod combined with a BCGvaccination and administration of valacyclovia hydrochlorine tablets.Imiquimod is commercially available from 3M Pharmaceuticals under thetrademark ALDARA™. A healthy human body produces the protein interferonalpha in response to an infection. Interferon alpha works to coat theinfection or virus in order to make the infection or virus vulnerable tothe human immune system. Imiquimod, i.e. ALDARA™ cream, turns intointerferon alpha once inside the human body, providing the neededinterferon alpha not adequately produced by the patient's own body.

In accordance with the present invention, ALDARA™ cream 5% is mixed at a1:1 ratio with H base cream. The ingredients of H base cream are:

-   -   water, glycerin, canola oil, stearic acid, cetyl alcohol,        PEG-100 stearate, glyceryl stearate, dimethicone, magnesium        aluminum silicate, propylene glycol, triethanolamine,        polysorbate 60, xanthan gum, bitter almond kernel oil, aloe        vera, grape seed extract, wheat germ oil, vitamin E acetate,        vitamin A palmitate, Vitamin C palmitate, tetrasodium EDTA,        potassium sorbate, diazolidinyl urea. H base cream is a        proprietary product produced by Professional Compounds Centers        of America and licensed by it.        The mixture of imiquimod and H base cream as described above is        administered transdermally, preferably by mixing ¼ cc ALDARA™ 5%        cream with ¼ cc H base cream and applying the resulting mixture        to various locations, i.e., the inner thigh, abdomen, hip, arms,        etc., of the patient. Various sites of administration prevent        any possible skin irritation. The foregoing amount of the        mixture of ALDARA™ 5% cream and H base cream is applied daily.        Tumor necrosis factor (also called TNFa, cachexin, or cachetin)        stimulates T-cells that coordinate the immune system. In a        healthy human body, tumor necrosis factor is released by white        blood cells and other tissues in response to damage caused by an        infection. Tumor necrosis factor is found in several vaccines.        The preferable vaccine to be used in accordance with the present        invention is the BCG vaccine, which is a common vaccine for        tuberculosis, given in the United States and around the world.        The tumor necrosis factor included in the BCG vaccine and        imiquimod, i.e. ALDARA™ cream, work together to stimulate the        T-cells and coordinate and improve the patient's immune system.        Interferon alpha coats the virus or infection in order to make        the virus or infection vulnerable to the tumor necrosis factor.

In accordance with the present invention, the vaccine is given in dosesof 0.1 mL (100 μg) once every three weeks as long as the treatmentcontinues. Valacyclovia hydrochlorine tablets, available fromGlaxoSmithKline under the trademark Valtrex™ is drug commonly used inthe treatment for genital herpes. In accordance with the presentinvention, Valtrex™ tablets are consumed twice daily in 500 mg doses.

The results of the procedure are monitored utilizing blood sugar metersand a diary to record ongoing blood sugar levels. Additionally, A-1-Cchecks track the patient's overall blood sugar levels over two to threemonth periods, and is the most effective way to track long-range successof the treatment. The treatment method regenerates islet cells, whichproduce insulin. Once the patient no longer depends on insulin tocorrect blood sugar levels, the treatment continues until the patienthas two or more sequential A-1-C checks in the target range, dependingon the judgment of the treating physician. Once treatment isdiscontinued, A-1-C checks continue, but at less frequent intervals asrecommended by the treating physician.

Although preferred embodiments of the invention have been illustrated inthe accompanying Drawings and described in the foregoing DetailedDescription, it will be understood that the invention is not limited tothe embodiments disclosed, but is capable of numerous rearrangements,modifications, and substitutions of parts and elements without departingfrom the spirit of the invention.

1-10. (canceled)
 11. A method of treating Type I diabetes comprising thesteps of: providing a quantity of ALDARA™ (imiquimod) 5% cream;providing a quantity of H base cream™; mixing ¼ cc. of the ALDARA™(imiquimod) 5% cream with ¼ cc. of the H base cream™ and transdermallyadministering the resulting mixture to the patient; administering avaccine containing tumor necrosis factor; and orally administeringVALTREX™ (valacyclovir) tablets.
 12. The method of treating Type Idiabetes according to claim 7 wherein the ALDARA™ (imiquimod) 5% cream/Hbase cream mixture is applied daily, the vaccine containing tumornecrosis factor is administered every three weeks and 500 mg VALTREX™(valacyclovir) tablets are orally administered twice daily.